Wireless Monitoring for Clinical Deterioration

NCT ID: NCT06644599

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

13160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-12-31

Brief Summary

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The study evaluates whether implementing a wireless monitoring system for patients admitted to hospital wards reduces mortality and cardiopulmonary failure.

Detailed Description

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The trial is designed as a stepped-wedge cluster RCT. Hospital wards (which constitute clusters in this design) will be randomized to have wireless monitoring, 7 wards at a time, with each 7 wards constituting a sequence. The study consists of 5 periods of two-month sequences followed by a one-month transition time with a phased introduction of the intervention. In the first period, all wards will have no wireless monitoring. After a baseline period of 2 (+1 washout) months, the intervention (monitoring system) will be implemented in a randomly selected new sequence every 3-month period until the intervention is implemented in all sequences.

Conditions

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Inpatient Facililty Diagnoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
The randomization list will be maintained with a research coordinator who is not involved in this trial, and the ward allocation will remain concealed from the research and clinical teams throughout the study and will be revealed for a given sequence only 1 month before the implementation of the intervention to allow training.

Study Groups

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Wireless monitoring

Wireless monitoring will be applied on patients who are at high risk, identified as having a National Early Warning Score (NEWS)-2 score of 5 or higher, patients with lower NEWS-2 scores if the clinical team has a clinical concern, patients with Critical Care Response Team (CCRT) activation regardless of NEWS-2 score and post-ICU discharges regardless of NEWS-2 score. The technology allows to have alarms for patients who meet preset thresholds for vital signs. These alarms are transmitted through a mobile device to the charge nurse of the related ward. The wireless system will be monitored 24/7 by a critical care nurse

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

Control

Usual care with no wireless monitoring.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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wireless monitoring

The monitoring wireless system will continuously monitor the heart rate, oxygen saturation (SpO2), respiratory rate, and blood pressure and in selected patients electrocardiography (ECG).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Ward level Inpatient wards, defined as wards used to manage adult inpatients.

Patient level

1. Aged 14 years or older
2. Checked in as inpatient status to one of the study wards

Exclusion Criteria

Ward level

1. Cardiology, pediatric, obstetric wards
2. ICUs and emergency departments
3. Operating rooms
4. Outpatient clinics
5. Daycare wards, endoscopy, outpatient procedure areas, hemodialysis units

Patient level No commitment for full life support at the time of arrival to the study ward (designated as Do-Not-Resuscitate status)
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Dr Yaseen Arabi

Chairman intensive care unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yaseen M Arabi, MD

Role: CONTACT

018011111 ext. 18899

References

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Other Identifiers

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ICT23R/006/08

Identifier Type: -

Identifier Source: org_study_id

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